A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
- Registration Number
- NCT00884312
- Lead Sponsor
- Amgen
- Brief Summary
This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and efficacy of long-term or continuing carfilzomib therapy for patients who previously completed a primary carfilzomib treatment study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Previous completion of a carfilzomib study within 90 days prior to first dose of maintenance study drug.
- Disease Assessments performed within 30 days prior to first dose of maintenance study drug.
- Written informed consent in accordance with federal, local, and institutional guidelines
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL, within 3 days prior to first dose of maintenance study drug.
- Subjects must agree to adhere to the study visit schedule and other study requirements and receive outpatient treatment and laboratory monitoring at the institution that administers the drug.
- Administration of an intervening chemotherapy between the time of previous carfilzomib study termination and first dose of maintenance study drug.
- Pregnant or lactating females
- Diagnosis of a new malignancy of a different tumor type.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Carfilzomib Carfilzomib Participants received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
- Primary Outcome Measures
Name Time Method Number of Participants With Peripheral Neuropathy From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.
Number of Participants With Adverse Events From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0.
Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade).
A serious AE is one that met one or more of the following criteria:
* Death
* Life threatening
* Required inpatient hospitalization or prolongation of an existing hospitalization
* Resulted in persistent or significant disability/incapacity
* A congenital anomaly/birth defect in the offspring of an exposed subject
* Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above.
- Secondary Outcome Measures
Name Time Method Overall Survival From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported.
Progression-free Survival From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first.
Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants.
PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.Time to Progression From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.
Trial Locations
- Locations (23)
Northwestern University
🇺🇸Chicago, Illinois, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Maryland, Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States
Pinnacle Oncology Hematology
🇺🇸Scottsdale, Arizona, United States
Winship Cancer Institute - Emory University
🇺🇸Atlanta, Georgia, United States
City of Hope National Medial Center
🇺🇸Duarte, California, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Weill Cornell Medical College
🇺🇸New York, New York, United States
University of Toronto, Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
The University of Texas, MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
John Theurer Cancer Center at Hackensack UMC
🇺🇸Hackensack, New Jersey, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Northwest Cancer Center
🇺🇸Houston, Texas, United States
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
University of California Medical Center
🇺🇸San Francisco, California, United States